Back to Search
Start Over
The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data.
- Source :
-
International journal of cardiology [Int J Cardiol] 2024 Feb 15; Vol. 397, pp. 131613. Date of Electronic Publication: 2023 Nov 27. - Publication Year :
- 2024
-
Abstract
- Background: Heart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population.<br />Methods: We conducted a retrospective pharmacovigilance study utilizing the FDA's database of safety reports (FAERS). We employed disproportionality analysis comparing Sac/Val to angiotensin receptor blockers (ARBs). We aim to evaluate the reporting of pre-defined adverse events associated with Sac/Val (hypotension, acute kidney injury (AKI), hyperkalemia and angioedema) in two age groups: adults (< 75 years) and older adults (≥ 75). For each subgroup, we calculated reporting odds ratio (ROR) and compared them by calculating P for interaction.<br />Results: The FAERS database encompassed 18,432 unique reports of Sac/Val. Of them, 12,630 (68.5%) subjects were adults (< 75 years), and 5802 (31.5%) were older adults (≥ 75 years), with a median age (IQR) of 68 (59-77). When compared to ARBs, Sac/Val was associated with higher reporting of hypotension, lower reporting of acute kidney injury (AKI) and hyperkalemia, and similar reporting of angioedema. Notably, we did not observe a significant interaction between the age subgroups and the risk estimates (AKI: P <subscript>interaction</subscript>  = 0.72, hyperkalemia: P <subscript>interaction</subscript>  = 0.94, hypotension: P <subscript>interaction</subscript>  = 0.31, and angioedema: P <subscript>interaction</subscript>  = 0.61).<br />Conclusions: In this postmarking study, none of the prespecified adverse events was reported more frequently in older adults. These findings provide reassurance for safety use of Sac/Val in older adults.<br /> (Copyright © 2023 Elsevier B.V. All rights reserved.)
- Subjects :
- Humans
Aged
Retrospective Studies
Tetrazoles adverse effects
Angiotensin Receptor Antagonists adverse effects
Pharmacovigilance
Angiotensin-Converting Enzyme Inhibitors
Valsartan adverse effects
Aminobutyrates adverse effects
Biphenyl Compounds adverse effects
Drug Combinations
Stroke Volume
Hyperkalemia chemically induced
Hyperkalemia diagnosis
Hyperkalemia epidemiology
Heart Failure epidemiology
Heart Failure chemically induced
Hypotension chemically induced
Hypotension diagnosis
Hypotension epidemiology
Angioedema chemically induced
Angioedema diagnosis
Angioedema epidemiology
Acute Kidney Injury chemically induced
Acute Kidney Injury diagnosis
Acute Kidney Injury epidemiology
Subjects
Details
- Language :
- English
- ISSN :
- 1874-1754
- Volume :
- 397
- Database :
- MEDLINE
- Journal :
- International journal of cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 38030039
- Full Text :
- https://doi.org/10.1016/j.ijcard.2023.131613